MalariaPhase 4CRITICalNCT07246525
Intermittent Preventive Treatment of Malaria in School-age Children to Decrease Community Transmission
A Phase 4 study testing dihydroartemisinin-piperaquine in people with Malaria, run by University of California, San Francisco at 1 site in Uganda.
Trial summary
The CRITICal study aims to estimate the effectiveness of intermittent preventive treatment in school children (IPTsc) with dihydroartemisinin-piperaquine (DP) for reducing community level malaria burden. Read more about this study
- Who is it for?
- Ages Up to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- dihydroartemisinin-piperaquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,800 participants
- Where
- 1 siteUganda
- Study dates
- 28 Sep 2026to 30 Sep 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child currently attending the participating school.
- Agreement of parent/guardian to provide informed consent.
- Agreement of children aged 8-17 years to provide assent.
Who cannot join
- Missing school on three consecutive days of the school survey.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda1 site
Infectious Diseases Research Collaboration
Kampala
Joaniter Nankabirwa, MBChB, MSc, PhD, jnankabirwa@yahoo.co.uk
About this study
Official title: Cluster Randomized Trial of Intermittent Preventive Treatment of Malaria in School-age Children to Improve the Health of Students and Decrease Community Transmission
The CRITICal study aims to estimate the effectiveness of intermittent preventive treatment in school children (IPTsc) with dihydroartemisinin-piperaquine (DP) for reducing community level malaria burden. Given that school-aged children are the primary drivers of transmission, the study hypothesis is that IPTsc will reduce this infectious reservoir and thus the burden of malaria in persons of all ages in surrounding communities.
Read the detailed description
The CRITICal study is an open label, phase IV, cluster-randomized trial to evaluate the effectiveness of IPTsc with DP administered approximately every 2 months to children attending primary school. Clusters are geographically defined target areas surrounding government-run health facilities previously established and referred to as Malaria Reference Centers (MRCs). A total of 24 clusters (MRCs) will be included in the study. These clusters were selected based on participation in an on-going sentinel site malaria surveillance network in areas with moderate-high malaria transmission intensity. Clusters will be randomized in a 1:1 ratio such that all primary schools serving the populations of each target area will either receive IPTsc or not receive IPTsc. The intervention will be delivered for 2 years and evaluations will continue for 1 additional year after the intervention is stopped. The primary outcome of the study will be malaria incidence within the population of the target areas. Secondary outcomes will include the the prevalence of parasitemia and molecular markers of DP resistance at the community level; the prevalence of parasitemia, anemia, and school attendance among children attending primary school; and estimates of the cost-effectiveness of IPTsc.
- Conditions
- Malaria
- Being tested
- dihydroartemisinin-piperaquine
- Keywords
- intermittent preventive treatment, school children, dihydroartemisinin-piperaquine
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dihydroartemisinin-piperaquineDrug
Also called D-Artepp
D-Artepp, is manufactured by Guilin Pharmaceutical Co Ltd, and is prequalified by the WHO and approved for use in Uganda by the National Drug Authority. Standard treatment doses of DP (once a day x 3 days) will be administered using weight-based guidelines targeting a total dose of 6.4 mg/kg dihydroartemisinin and 51.2 mg/kg of piperaquine as per manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| IPTsc | Experimental | DP will be administered approximately every 2 months for two years to all eligible children enrolled in primary schools serving the target areas from clusters randomized to the interventional arm. Receives: Drug: dihydroartemisinin-piperaquine |
| No IPTsc | No intervention | No IPTsc (standard of care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases of laboratory-confirmed malaria diagnosed among patients residing in the target area during the period the intervention is implemented
malaria incidence: the number of cases of laboratory-confirmed malaria diagnosed at the MRC among patients residing in the target area, per unit time, divided by the total population of the target area in patients of all ages over the 24-month intervention period
Measured: 24 months after intervention implemented
Secondary outcomes (13)
Number of cases of laboratory-confirmed malaria diagnosed among patients residing in the target area after the intervention is competed
malaria incidence: the number of cases of laboratory-confirmed malaria diagnosed at the MRC among patients residing in the target area, per unit time, divided by the total population of the target area in patients of all ages 12 months after intervention is completed
Measured: 12 months after intervention is completed
Parasite prevalence among community residents 12 months after the intervention is implemented
Proportion of blood smears positive for parasites by microscopy at the time of community cross-sectional surveys
Measured: 12 months after the intervention is implemented
Parasite prevalence among community residents 24 months after the intervention is implemented
Proportion of blood smears positive for parasites by microscopy at the time of community cross-sectional surveys
Measured: 24 months after the intervention is implemented
Parasite prevalence among community residents 12 months after the intervention is completed
Proportion of blood smears positive for parasites by microscopy at the time of community cross-sectional surveys
Measured: 12 months after the intervention is completed
Prevalence of molecular markers of DP resistance from parasite positive samples from community surveys 12 months after the intervention is implemented
Proportion of parasite positive samples with molecular markers of DP resistance detected
Measured: 12 months after the intervention is implemented
Prevalence of molecular markers of DP resistance from parasite positive samples from community surveys 24 months after the intervention is implemented
Proportion of parasite positive samples with molecular markers of DP resistance detected
Measured: 24 months after the intervention is implemented
Prevalence of molecular markers of DP resistance from parasite positive samples from community surveys 12 months after the intervention is completed
Proportion of parasite positive samples with molecular markers of DP resistance detected
Measured: 12 months after the intervention is completed
Parasite prevalence among schoolchildren 12 months after the intervention is implemented
Proportion of blood smears positive for parasites by microscopy at the time of school surveys
Measured: 12 months after the intervention is implemented
Parasite prevalence among schoolchildren 24 months after the intervention is implemented
Proportion of blood smears positive for parasites by microscopy at the time of school surveys
Measured: 24 months after the intervention is implemented
Parasite prevalence among schoolchildren 12 months after the intervention is completed
Proportion of blood smears positive for parasites by microscopy at the time of school surveys
Measured: 12 months after the intervention is completed
Anemia prevalence among schoolchildren 12 months after the intervention is implemented
Proportion of children with anemia at the time of school surveys
Anemia defined based on WHO criteria as:
- hemoglobin less than 11.5g/dl in children 5 - 11 years of age;
- hemoglobin less than 12.0g/dl in children 12 - 14 years of age and non-pregnant girls 15 years and above; and
- hemoglobin less than 13.0g/dl in boys 15 years and above) 12 and 24 months after the intervention is implemented and school attendance (defined as the number of days attending school / number of days school in session) over the 24-month intervention period
Measured: 12 months after the intervention is implemented
Anemia prevalence among schoolchildren 24 months after the intervention is implemented
Proportion of children with anemia at the time of school surveys
Anemia defined based on WHO criteria as:
- hemoglobin less than 11.5g/dl in children 5 - 11 years of age;
- hemoglobin less than 12.0g/dl in children 12 - 14 years of age and non-pregnant girls 15 years and above; and
- hemoglobin less than 13.0g/dl in boys 15 years and above) 12 and 24 months after the intervention is implemented and school attendance (defined as the number of days attending school / number of days school in session) over the 24-month intervention period
Measured: 24 months after the intervention is implemented
Anemia prevalence among schoolchildren 12 months after the intervention is completed
Proportion of children with anemia at the time of school surveys
Anemia defined based on WHO criteria as:
- hemoglobin less than 11.5g/dl in children 5 - 11 years of age;
- hemoglobin less than 12.0g/dl in children 12 - 14 years of age and non-pregnant girls 15 years and above; and
- hemoglobin less than 13.0g/dl in boys 15 years and above) 12 and 24 months after the intervention is implemented and school attendance (defined as the number of days attending school / number of days school in session) over the 24-month intervention period
Measured: 12 months after the intervention is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start28 Sep 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be an open label, phase IV, cluster-randomized trial to evaluate the effectiveness of IPTsc with DP administered approximately every 2 months to children attending primary school. Clusters are geographically defined target areas surrounding government-run health facilities previously established and referred to as Malaria Reference Centers (MRCs). A total of 24 clusters (MRCs) will be included in the study. These clusters were selected based on participation in an on-going sentinel site malaria surveillance network in areas with moderate-high malaria transmission intensity. Clusters will be randomized in a 1:1 ratio such that all primary schools serving the populations of each target area will either receive IPTsc or not receive IPTsc.
- Masking
- None (open label)
- Enrolment
- 4,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Infectious Diseases Research Collaboration, Uganda, Ministry of Health, Uganda
- Responsible party
- Sponsor
- Investigators
- Grant Dorsey, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246525
- Sponsor's protocol ID
- CRITICal
- Other IDs
- U01AI186861
- Acronym
- CRITICal
- Status last verified
- Sep 2026
- First submitted
- 14 Nov 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Randomized Trial of Intermittent Preventive Treatment of Malaria in School-age Children to Improve the Health of Students and Decrease Community Transmission
- ClinicalTrials.gov ID
- NCT07246525
- Acronym / sponsor ID
- CRITICal / CRITICal
- Conditions
- Malaria
- Keywords
- intermittent preventive treatment, school children, dihydroartemisinin-piperaquine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,800 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Infectious Diseases Research Collaboration, Uganda, Ministry of Health, Uganda
- Study start
- 28 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The CRITICal study aims to estimate the effectiveness of intermittent preventive treatment in school children (IPTsc) with dihydroartemisinin-piperaquine (DP) for reducing community level malaria burden. Given that school-aged children are the primary drivers of transmission, the study hypothesis is that IPTsc will reduce this infectious reservoir and thus the burden of malaria in persons of all ages in surrounding communities.
Detailed description
The CRITICal study is an open label, phase IV, cluster-randomized trial to evaluate the effectiveness of IPTsc with DP administered approximately every 2 months to children attending primary school. Clusters are geographically defined target areas surrounding government-run health facilities previously established and referred to as Malaria Reference Centers (MRCs). A total of 24 clusters (MRCs) will be included in the study. These clusters were selected based on participation in an on-going sentinel site malaria surveillance network in areas with moderate-high malaria transmission intensity. Clusters will be randomized in a 1:1 ratio such that all primary schools serving the populations of each target area will either receive IPTsc or not receive IPTsc. The intervention will be delivered for 2 years and evaluations will continue for 1 additional year after the intervention is stopped. The primary outcome of the study will be malaria incidence within the population of the target areas. Secondary outcomes will include the the prevalence of parasitemia and molecular markers of DP resistance at the community level; the prevalence of parasitemia, anemia, and school attendance among children attending primary school; and estimates of the cost-effectiveness of IPTsc.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will be an open label, phase IV, cluster-randomized trial to evaluate the effectiveness of IPTsc with DP administered approximately every 2 months to children attending primary school. Clusters are geographically defined target areas surrounding government-run health facilities previously established and referred to as Malaria Reference Centers (MRCs). A total of 24 clusters (MRCs) will be included in the study. These clusters were selected based on participation in an on-going sentinel site malaria surveillance network in areas with moderate-high malaria transmission intensity. Clusters will be randomized in a 1:1 ratio such that all primary schools serving the populations of each target area will either receive IPTsc or not receive IPTsc.
| Arm | Type | Receives |
|---|---|---|
| IPTsc | Experimental | Drug: dihydroartemisinin-piperaquineDP will be administered approximately every 2 months for two years to all eligible children enrolled in primary schools serving the target areas from clusters randomized to the interventional arm. |
| No IPTsc | No intervention | –No IPTsc (standard of care) |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child currently attending the participating school.
- Agreement of parent/guardian to provide informed consent.
- Agreement of children aged 8-17 years to provide assent.
Key exclusion criteria (1 listed)
- Missing school on three consecutive days of the school survey.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dihydroartemisinin-piperaquineAlso: D-ArteppD-Artepp, is manufactured by Guilin Pharmaceutical Co Ltd, and is prequalified by the WHO and approved for use in Uganda by the National Drug Authority. Standard treatment doses of DP (once a day x 3 days) will be administered using weight-based guidelines targeting a total dose of 6.4 mg/kg dihydroartemisinin and 51.2 mg/kg of piperaquine as per manufacturer's instructions. | Drug | IPTsc |
Primary outcome
Number of cases of laboratory-confirmed malaria diagnosed among patients residing in the target area during the period the intervention is implemented
Time frame: 24 months after intervention implemented
malaria incidence: the number of cases of laboratory-confirmed malaria diagnosed at the MRC among patients residing in the target area, per unit time, divided by the total population of the target area in patients of all ages over the 24-month intervention period
13 secondary outcomes
Number of cases of laboratory-confirmed malaria diagnosed among patients residing in the target area after the intervention is competed
Time frame: 12 months after intervention is completed
Parasite prevalence among community residents 12 months after the intervention is implemented
Time frame: 12 months after the intervention is implemented
Parasite prevalence among community residents 24 months after the intervention is implemented
Time frame: 24 months after the intervention is implemented
Parasite prevalence among community residents 12 months after the intervention is completed
Time frame: 12 months after the intervention is completed
Prevalence of molecular markers of DP resistance from parasite positive samples from community surveys 12 months after the intervention is implemented
Time frame: 12 months after the intervention is implemented
Prevalence of molecular markers of DP resistance from parasite positive samples from community surveys 24 months after the intervention is implemented
Time frame: 24 months after the intervention is implemented
Prevalence of molecular markers of DP resistance from parasite positive samples from community surveys 12 months after the intervention is completed
Time frame: 12 months after the intervention is completed
Parasite prevalence among schoolchildren 12 months after the intervention is implemented
Time frame: 12 months after the intervention is implemented
Parasite prevalence among schoolchildren 24 months after the intervention is implemented
Time frame: 24 months after the intervention is implemented
Parasite prevalence among schoolchildren 12 months after the intervention is completed
Time frame: 12 months after the intervention is completed
Anemia prevalence among schoolchildren 12 months after the intervention is implemented
Time frame: 12 months after the intervention is implemented
Anemia prevalence among schoolchildren 24 months after the intervention is implemented
Time frame: 24 months after the intervention is implemented
Anemia prevalence among schoolchildren 12 months after the intervention is completed
Time frame: 12 months after the intervention is completed
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Grant Dorsey, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dihydroartemisinin-piperaquine in people with Malaria, run by University of California, San Francisco at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grant Dorsey, MD, PhD (415-310-0525, grant.dorsey@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cases of laboratory-confirmed malaria diagnosed among patients residing in the target area during the period the intervention is implemented (time frame: 24 months after intervention implemented). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.